SORIN GROUP DEUTSCHLAND SORIN HEATER-COOLER SYSTEM 3T; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
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Catalog Number N/A |
Device Problem
Insufficient Information (3190)
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Patient Problem
Bacterial Infection (1735)
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Event Date 11/27/2013 |
Event Type
Injury
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Manufacturer Narrative
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The model and serial number have not been disclosed by the facility.This information will be provided if and when made available.Mfg date: a serial number has not been disclosed by the facility and so the manufacture date cannot be determined.This information will be provided if and when made available.Pma 510(k): the model number has not been disclosed by the facility and so the 510k number cannot be determined.Sorin group (b)(4) manufactures the sorin heater-cooler system 3t.The incident occurred in (b)(6).This medwatch report is being filed on behalf of sorin group.Sorin group (b)(4) received a customer medwatch # (b)(4) stating that a patient was identified/diagnosed with a non-tuberculosis mycobacterium (ntm) infection after undergoing open heart surgery which used a sorin heater-cooler system 3t.The facility has not been able to confirm that the patient infection is related to the use of the sorin heater-cooler system 3t.Two other user reports with the same description were received (3902560000-2015-8045 and 3902560000-2015-8047), however it is not yet known if the same patient is being referenced in all 3 reports.The medwatch reports 9611109-2015-00662 and 9611109-2015-00664 were submitted for user reports 3902560000-2015-8045 and 3902560000-2015-8047, respectively.Multiple requests have been made for information regarding the patient outcome and confirmation of any contamination of the involved device.At this time, the facility has not disclosed any additional information to sorin group deutschland.The serial number has not been provided by the facility, so a dhr review cannot be performed at this time the investigation is ongoing.A follow-up report will be sent when the investigation is complete.
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Event Description
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Sorin group (b)(4) received a customer medwatch # (b)(4) stating that a patient was identified/diagnosed with a non-tuberculosis mycobacterium (ntm) infection after undergoing open heart surgery which used a sorin heater-cooler system 3t.The facility has not been able to confirm that the patient infection is related to the use of the sorin heater-cooler system 3t.
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Manufacturer Narrative
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Sorin group (b)(4) manufactures the sorin heater-cooler system 3t.The incident occurred in (b)(6).This medwatch report is being filed on behalf of sorin group (b)(4).Sorin group (b)(4) received a customer medwatch # (b)(4) stating that a patient was identified/diagnosed with a non-tuberculosis mycobacterium (ntm) infection after undergoing open heart surgery which used a sorin heater-cooler system 3t.The facility has not been able to confirm that the patient infection is related to the use of the sorin heater-cooler system 3t.Multiple attempts were made to contact the customer regarding the serial number(s) of the involved unit(s) and their current status.Additionally, information about the number of patients and their clinical outcomes was requested.None of these attempts were successful.To date, sorin group deutschland has not received confirmation that any of the units in use at milton s hershey medical center are contaminated.No device information was provided by the facility, so a dhr review could not be performed.As no new information has been received from the customer, further investigation is not possible.
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